NEW YORK (GenomeWeb News) – A Sequenom official yesterday provided an update on the firm's timeline for commercialization of its highly anticipated trisomy 21 non-invasive, pre-natal test.
Speaking to investors at the UBS Global Life Sciences Conference here Ronald Lindsay, Sequenom's SVP of R&D, said that the firm is on schedule to launch a laboratory-developed test in the fourth quarter of 2011. The firm is currently conducting trials on the sequencing-based test, and intends to submit its study results for publication in the third or fourth quarter of next year.
In addition, Lindsay said that Sequenom hopes to file a Premarket Approval application with the US Food and Drug Administration in the second half of 2012, which is in line with the timeline it initially put forth during its first-quarter conference call in May.
San Diego-based Sequenom is rebounding from a scandal over the mishandling of test data on the Down syndrome test, which eventually led to the dismissal of President and CEO Harry Stylli and other executives.
Lindsay noted that the firm is developing the test to run on Illumina's HiSeq 2000 next-generation sequencing platform, which was launched early this year. Asked during a question-and answer session why the firm chose sequencing rather than digital PCR, Lindsay said that studies have thus far shown that sequencing works for the test, whereas he has heard others have had difficulties in getting accurate enough results with digital PCR.
Lindsay said that Sequenom intends to commercialize the test on its own in the US, but it will likely look for partners elsewhere.
In addition to providing an update on the T21 test, Lindsay noted that company officials met with the FDA last week to discuss a warning letter the firm received this summer claiming that it was improperly marketing the SEQureDx prenatal genetic diagnostic test. He said the firm clarified for the agency that it is not selling the test directly to consumers, and that the test is only available through a physician. He added that the FDA concluded that it had no further questions, and the firm believes the inquiry has been closed.
Sequenom Interim CFO Paul Maier also noted that the company would need to raise additional funds and intends to do so in the next six months. As of June 30, the company had $67.7 million in cash, cash equivalents, and marketable securities, which is enough to support its operations until around May, he said.